Recall Z-0144-2014
Insight Instruments, Inc. · initiated June 27, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Codes / lots: Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014
Reason for recall
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
FDA-determined cause: No Marketing Application
Action taken
Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342. Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement. For questions regarding this recall call 727-219-9393.
Details
- Recall number
- Z-0144-2014
- Initiated
- June 27, 2013
- Posted by FDA
- November 4, 2013
- Terminated
- September 27, 2017
- Product code
- HNJ – Punch, Corneo-Scleral
- Quantity
- 10212
- Distribution
- Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.
- Recalling firm
- Insight Instruments, Inc., Stuart, FL